SMITH & NEPHEW, INC. NS VIS ADPT GUIDE LGNP KIT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
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Model Number V0200109 |
Device Problems
Nonstandard Device (1420); Positioning Problem (3009)
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Patient Problem
Laceration(s) (1946)
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Event Date 08/23/2022 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, during a tka, using an ns vis adpt guide lgnp kit for legion primary cr tka surgery caused notching during the anterior resection due to engineer¿s alignment.The procedure was resumed, after a non significant delay, with a change in surgical technique.No other complications reported.Patient is healthy and recovering normally from surgery.
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Event Description
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It was reported that, during a visionaire-assisted tka with legion primary cr, the surgeon caused notching during the anterior resection due to engineer¿s alignment to design the block.The procedure was completed, after a non-significant delay, with a change in surgical technique.No other complications reported.Patient is healthy and recovering normally from surgery.
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, reportedly, the anterior notching was ¿due to engineer¿s alignment¿.Based on the documentation provided, no clinical factors have been identified which would have contributed to the reported event.The assessed patient impact includes the anterior notching, the reported slight (0-30 minute) surgical delay, and the anticipated post-operative rehabilitative phase.Although controversial, anterior notching has been associated with a possible increased risk for periprosthetic fractures and early revision; however, this cannot be concluded.Per correspondence, the patient is healthy and recovering normally.Further patient impact cannot be determined.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of instructions for use for visionaire¿ patient matched instrumentation with fastpak instruments revealed that if the patient matched cutting guide does not perform as intended, use the standard smith & nephew instrumentation to complete the surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.A review made by the quality engineering team revealed that after a thorough review of the device standards, the engineering team could not determine a root cause for this complaint.All parts of the designed device were within the visionaire standards.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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